The purpose of this study is to find out what effects (good and bad) SAMITAL (Vaccinium myrtillus extract/Macleaya cordata alkaloids/Echinacea angustifolia extract granules) has on the management of mucositis (inflammation and ulceration that occurs in the mouth) brought on by chemotherapy and radiation therapy for squamous cell carcinoma of the head and neck

Proportion of patients with severe mucositis (WHO score 3 or 4) [ Time Frame: Up to 3 months after completion of study treatment ] [ Designated as safety issue: No ]

The 2 treatment groups will be compared using the Mantel-Haenszel test, stratified by disease site and type of therapy, using a two-sided test at the alpha= 0.10 level of significance. Since emphasis is placed on the accurate estimation of treatment effect for use in the planning of a future confirmatory trial, corresponding estimates of effect size will also be computed along with 90% confidence intervals.

Secondary Outcome Measures:

Severity and duration of mucositis as assessed by dichotomized WHO Mucositis Global Severity Score (0-2 vs 3-4) and/or OMDQ scores [ Time Frame: Up to 3 months after completion of study treatment ] [ Designated as safety issue: No ]

The 2 treatment groups will be compared. The Mantel-Haenszel test, stratified by disease site and type of therapy, will be used for these comparisons.

Quality of life as assessed by EORTC QLQ-C30 questionnaire (with 1 being not at all and 4 being very much) [ Time Frame: Up to 3 months after completion of study treatment ] [ Designated as safety issue: No ]

The 2 treatment groups will be compared. Will be analyzed using Mann-Whitney U tests. All secondary analyses will be carried out using two-sided tests at the 10% level of significance.

Quality of Life as assessed by EORTC QLQ Head and Neck Cancer-Specific Module function and symptom sub-scores between groups (with 1 being not at all and 4 being very much) [ Time Frame: Up to 3 months after completion of study treatment ] [ Designated as safety issue: No ]

The 2 treatment groups will be compared. Will be analyzed using Mann-Whitney U tests. All secondary analyses will be carried out using two-sided tests at the 10% level of significance.

Beginning as soon as symptoms arise during chemoradiotherapy, patients receive placebo PO QID. Patients may continue to receive placebo for up to 4 weeks after completion of radiation therapy for a maximum of 11 weeks.

Other: placebo

Given PO

Other Name: PLCB

Procedure: quality-of-life assessment

Ancillary studies

Other Name: quality of life assessment

Other: questionnaire administration

Ancillary studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the tolerability of SAMITAL granules for suspension. II. To assess the efficacy of SAMITAL granules for suspension in reducing the incidence of severe mucositis (World Health Organization [WHO] mucositis scale score of 3 or 4) induced by concurrent chemoradiation for head and neck cancer (HNC).

SECONDARY OBJECTIVES:

I. To assess the effect of SAMITAL granules for suspension on the severity and duration of mucositis (WHO mucositis scale and patient self-assessment with the Oral Mucositis Daily Questionnaire [OMDQ]).

II. To assess the effect of SAMITAL granules for suspension on validated patient reported quality of life measures (European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [QLQ]-C30 and EORTC QLQ Head and Neck Cancer Specific Module).

ARM II: Beginning as soon as symptoms arise during chemoradiotherapy, patients receive placebo PO QID. Patients may continue to receive placebo for up to 4 weeks after completion of radiation therapy for a maximum of 11 weeks.

After completion of study treatment, patients are followed up for 3 months.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

Patients with no distant metastatic disease

Have histologically proven diagnosis of squamous cell carcinoma (stage III - IV) of the paranasal sinuses, nasopharynx, larynx, hypopharynx, oral cavity and/or oropharynx; treated with definitive concurrent chemoradiotherapy; OR histologically proven diagnosis of squamous cell carcinoma of the paranasal sinuses, nasopharynx, larynx, hypopharynx, or oropharynx with finding of need for concurrent chemoradiotherapy (extracapsular extension, positive surgical margin, more than one lymph node positive, stage III - IV disease, perineural invasion, vascular tumor embolus); other rare histologies which are treated as per the guidelines of this protocol may be allowed with approval of the medical monitor

Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

Contraindication to full course chemoradiotherapy

ECOG performance status >= 3

Presence of distant metastatic disease

Surgery with significant defect or flap in the oral cavity

Poor dentition, ill-fitting dental appliances, obturators or any kind of resection prosthesis (can be enrolled if this can be corrected by a dentist prior to start of radiation therapy)

Presence of other medical conditions causing mucositis (e.g., rheumatologic, severe gastroesophageal reflux, etc. at the discretion of the physician)

Previous radiotherapy on head and neck district involving mucosa of oral cavity and/or oropharynx

Use of chronic immunosuppressive drugs

Brachytherapy or interstitial implantation treatment

Other medical conditions that could make the patient not able to comply with the treatment

Requirement of chronic steroid therapy (except when given for laryngeal edema)

Pregnant or nursing female patients

Unwilling or unable to follow protocol requirements

Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug

Received an investigational agent within 30 days prior to enrollment

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01674374